a single-center pilot study evaluating a preemptive short course of glecaprevir/pibrentasvir in hepatitis c positive to negative kidney transplantation

Conditions: ESRD

Summary: the purpose of this research study is to evaluate the feasibility of a 2 week course of glecaprevir/pibrentasvir (mavyret) starting immediately prior to transplantation to treat hepatitis c virus (hcv) in kidney transplant recipients who receive a kidney from a donor with hcv.

this is a prospective, open-label, single-center, pilot study. the patient population will include 20 patients who are on the kidney transplant waitlist at nyu langone health, are hepatitis c virus (hcv) negative, are willing to accept an organ from an hcv positive donor, and consent to participate in this trial. study subjects will receive a kidney transplant from a deceased donor who tested positive for hcv as confirmed by nucleic acid amplification testing (nat) per standard of care. all study subjects will receive a two week course of preemptive therapy with glecaprevir/pibrentasvir (mavyret®), starting on postoperative day (pod) 0 prior to the transplant. if hcv rna is undetectable after 2 weeks of therapy, mavyret will be discontinued and study subjects will be followed with an intensive hcv monitoring protocol. if hcv rna is detectable after 2 weeks of therapy, mavyret will be continued to complete a full course of 8 weeks per standard of care. all patients will undergo close monitoring and surveillance for hcv viremia post-transplant to ensure that sustained virologic response (svr) is achieved.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * listed for kidney transplantation at nyu langone health and willing to accept hcv positive donor organs * able to complete routine post-transplant visits and study visits for a minimum of 1 year after transplantation * women of childbearing potential must agree to use birth control in accordance with mycophenolate risk evaluation and mitigation stategy (rems) after transplant due to increased risk of birth defects and/or miscarriage * both men and women must agree to use at least one barrier method of contraception after transplant to prevent any secretion exchange * able and willing to provide informed consent * receive an organ offer for a kidney from a deceased donor that: * is hcv nat positive * meets all standard criteria for organ acceptability at nyu langone transplant institute exclusion criteria: * hcv rna positive or history of previously treated hcv * evidence of active hepatitis b infection or on active antiviral treatment of hbv * hiv positivity * pregnant or nursing (lactacting) women * current use of atazanavir or rifampin * known hypersensitivity to glecaprevir and/or pibrentasvir * current or history of decompensated liver disease * recipients of dual organs (i.e. simultaneous liver and kidney transplant, simultaneous kidney and pancreas transplant, or simultaneous heart and kidney transplant) * receive an organ offer for a kidney from a deceased donor that is: * confirmed hiv positive * confirmed hbv positive (positive hepatitis b surface antigen, and/or detectable hepatitis b virus dna) * known to have previously failed daa therapy for treatment for hcv * hcv antibody positive, but nat negative